PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS). VHIR Pilot.

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Intervention 1; Behavioral: Intervention 2

• Registration Number: NCT02818790
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

The goal of the MI field test is to assess users' overall satisfaction, usability and acceptability of the PRECIOUS system, and to explore if MI in combination with gamification principles is a feasible solution to foster adherence to PRECIOUS system. Moreover, it is pursued to trigger behavior change and build up motivation to maintain sustained change towards healthy lifestyles. The field test at University Hospital Vall d'Hebron will be carried out with morbidly obese pre-diabetic patients. This pilot test will serve to explore users' acceptance of PRECIOUS system in an early stage of its development. Considering that this is a pilot test, feedback and outcomes obtained will serve to refine and adjust PRECIOUS system concept and architecture.

Detailed Description

The pilot test will recruit 30 morbidly obese pre-diabetic patient and they will be randomized into three groups: Group 1. Treatment as usual; Group 2. PRECIOUS system; Group 3. PRECIOUS system and Motivational Interviewing counseling. Researchers of this study will contact telephonically with potential participants and will ask for voluntary participation. Among those who agree, a face-to-face appointment at the reference hospital will be scheduled. In this appointment, general information on the study objectives and procedures will be offered.

The length of intervention will be 3 months with the following scheduled follow-up appointments: week 2 (considering baseline as week 1), week 5, week 8 and week 12. In the follow-up appointments 2, 5 and 8, only doubts and questions regarding system use will be addressed (not specific measures will be collected). Two types of measures will be assessed: 1) Primary outcome measures (at the end of the test) to assess usability, satisfaction, user's acceptance, and effectiveness of PRECIOUS system; and 2) Secondary outcome measures (baseline and final assessment) to assess different aspects of lifestyle and health habits. In addition, all patients will use a device to record heart rate during 3 consecutive days (week 1 and 12).

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-30
• Primary Completion: 2016-07
• Study Completion: 2016-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All patients must be under the care of medical specialists who adheres to national guidelines for morbid obesity or pre-diabetic conditions.
• Age older than 18 years.
• Body max index (BMI): ≥ 30 mg/m2.
• Pre-diabetic condition following ADA criteria: fasting plasma glucose level from 5.6mmol/L (100 mg/dL) to 6.9mmol/L (125 mg/dL).
• Patients must be able to participate, understand and complete questionnaires in Spanish language.
• Patients must refer to be used to use multimedia platforms such as PDAs, tablets, laptops, smart phones or personal computers in a regular basis.

Exclusion Criteria

• Any mental (e.g. cognitive impairment, severe psychopathology not stabilized) or physical condition that could interfere with the successful application of the research protocol.
• Patients will be recruited from specialist outpatient consultation at Vall d'Hebron Research Institute (VHIR). All patients must be under the care of specialists who adhere to national guidelines.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2. Intervention 1	Intervention 1	-
Group 2. Intervention 2	Intervention 2	-

Primary Outcome Measures

Name	Time	Method
User's acceptance of the PRECIOUS system	At the end of the test (Session 5, week 12)	o 4 Numeric scales 0-10, based on QUIS7
Patients' subjective assessment of usability of the PRECIOUS system	At the end of the test (Session 5, week 12)	o Numeric scale 0-10 \& 10 items, 5-point Likert Scale, 0-100
Satisfaction with the PRECIOUS system	At the end of the test (Session 5, week 12)	o 16 Numeric scales 0-10
Effectiveness of the PRECIOUS system	At the end of the test (Session 5, week 12)	o Difference between the control group and the intervention groups regarding engagement and adherence to targeted healthy habits based on MCID between groups of the PRECIOUS system.

Secondary Outcome Measures

Name	Time	Method
Demographics and clinical data	Session 1 (week 1) and Session 5 (week 12)	o Ad hoc protocol (17 items)
Health-related quality of life	Session 1 (week 1) and Session 5 (week 12)	o SF12v2: 12 items
Weight management	Session 1 (week 1) and Session 5 (week 12)	o S-Weight (5 items) \& P-Weight (34 items)
Severity of the core symptoms of Depression, Anxiety & Stress	Session 1 (week 1) and Session 5 (week 12)	o DASS (21 items)
Physical activity	Continuous measure (intervention groups)	o Data provided by the app
Nutritional habits	Continuous measure (intervention groups)	o Data provided by the app
Alcohol consumption	Session 1 (week 1) and Session 5 (week 12)	o Audit (10 items)
Tobacco use	Session 1 (week 1) and Session 5 (week 12)	o Fagerström (6 items)
Sleep quality	Session 1 (week 1) and Session 5 (week 12)	o Pittsburg Quality of Sleep index (18 items)
Assessment of the motivational aspects of PRECIOUS	Session 5 (week 12) Intervention groups	o 23 numeric scales 0-10
Bodyguard 2 device	Session 1 (week 1) and Session 5 (week 12)	Heart Rate Variability measurement

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry; 🇪🇸 Barcelona, Spain